Drug Recall: Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Directions: Tap the bottle to release the powder. Add 50mL of water to the bottle and shake vigorously f
Lupin Pharmaceuticals Inc. · February 5, 2024
Reason for Recall
Labeling: Incorrect or Missing Package Insert
Product Description
Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Directions: Tap the bottle to release the powder. Add 50mL of water to the bottle and shake vigorously for 1 minute. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202. NDC: 43386-038-60.
Distribution
OH, IL, NJ
States Affected
IL, NJ, OH
Quantity Affected
N/A
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0337-2024
Status: terminated
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